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RECRUITING
NCT07444320
NA

Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System

Sponsor: Boston Scientific Corporation

View on ClinicalTrials.gov

Summary

This is a multicenter, prospective, single-arm, feasibility study to evaluate the safety and effectiveness of the waveforms being delivered using the FARAPULSE PFA System in patients with Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation (PersAF).

Official title: A Multicenter Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System in Patients With Atrial Fibrillation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-02-12

Completion Date

2028-02

Last Updated

2026-03-31

Healthy Volunteers

No

Interventions

DEVICE

FARAPULSE™ Pulsed Field Ablation (PFA) System

The FARAWAVE™ PFA Catheter will be used to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARASTAR™ Generator will be used in conjunction with the FARAWAVE™ PFA Catheter to deliver the investigational waveform(s) for the isolation of pulmonary veins and posterior wall in the treatment of paroxysmal and persistent atrial fibrillation. The FARADRIVE™ Steerable Sheath will be used for percutaneous catheter introduction into the chambers of the heart, including the left side of the heart through the interatrial septum.

Locations (2)

Klinicki Bolnicki Centar Split

Split, Croatia

Na Homolce Hospital

Prague, Czechia